BERRY POWERFUL LIP CARE- dimethicone jelly 
JAFRA COSMETICS INTERNATIONA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Royal Jelly Berry Powerful Lip Care

Active ingredient      Purpose

Dimethicone 2.0%    Skin protectant

Uses

Helps prevent and temporarily chapped or cracked lips

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

Warnings

For external use only

When using this product do not get into eyes

Do not use deep on

Directions

Apply as needed.

Inactive ingredients

Beeswax/Cera Alba, Benzyl Benzoate, Boron Nitride, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Diglyceryl Adipate/Caprate/Caprylate/Hydroxystearate/Isostearate/Stearate, Dipropylene Glycol, Ethylhexylglycerin, Flavor/Aroma, Glycerin, Glycine Soya  (Soybean) Germ Extract, Hydrogenated Lecithin, Lecithin, Maltodextrin, Microcrystalline Wax (Cera Microcrystallina), Oryza Sativa (Rice) Bran Extract, Phenethyl Alcohol, Phospholipids, Phytosteryl Canola Glycerides, Polyglyceryl-3 Diisostearate, Prunus Amygdalus dulcis (sweet Almond) Oil. Prunus Armeniaca (Apricot) Kernel Oil, Ricinus Communis (castor) seed Oil, Silica Dimethyl Silylate, Silica, Terapeptide-45, Theobroma Cocoa Seed Butter, Tocopherol Acetate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water, Zea Mays (Corn) Starch.

Jafra Royal Jelly

Berry Powerful Lip Care

4 g NET WT .14 oz

carton

BERRY POWERFUL LIP CARE 
dimethicone jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-278
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL BENZOATE (UNII: N863NB338G)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOYBEAN GERM (UNII: JBW2VHD14M)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
RICE BRAN (UNII: R60QEP13IC)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
ALMOND OIL (UNII: 66YXD4DKO9)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
CASTOR OIL (UNII: D5340Y2I9G)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
WATER (UNII: 059QF0KO0R)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-278-021 in 1 CARTON10/13/2017
1NDC:68828-278-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/13/2017
Labeler - JAFRA COSMETICS INTERNATIONA (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-278)

Revised: 6/2020
Document Id: a8b440d1-7f12-3699-e053-2a95a90a7a48
Set id: 3bcd8012-7ec1-4dea-aa9d-5eb4abf7f09b
Version: 4
Effective Time: 20200622
 
JAFRA COSMETICS INTERNATIONA